The fat mass, estimated glomerular filtration rate, and chronic inflammation in type 2 diabetic patients.

BACKGROUND: The aim of the study was to analyze the degree of obesity and its associations with age, gender, inflammation, an estimated glomerular filtration rate (eGFR), and liver function in type 2 diabetes mellitus (T2DM) patients. METHODS: A total of 874 consecutive adult Caucasian T2DM patients from outpatient diabetic clinic were included in the study. The relative fat mass (RFM) and body mass index (BMI) were used as obesity markers. Serum creatinine and cystatin C were used for the GFR estimation. Serum high-sensitive C-reactive protein (hsCRP) was used as the indicator of inflammation. RESULTS: The median, interquartile range (IQR) of RFM in females was higher than that in males (44.8 (42.3-47.2) % vs 31.3 (28.8-34.1) %, respectively; P < .0001). The median (IQR) of BMI in females was no higher than that in males (30 (27-34) kg/m2 vs 30 (27-34), respectively; P = .5152). The obesity prevalence was 99% in males and 98% in females according to RFM. BMI recognized obesity in 51% males and 53% females. RFM was positively associated with hsCRP in both males (rs  = .296, P < .0001) and females (rs  = .445, P < .0001). ALT was positively correlated with eGFRcys in both males (rs  = .379, P < .0001) and females (rs  = .308, P < .0001). CONCLUSION: The RFM equation leads to higher obesity prevalence compared to BMI. Women have higher RFM compared to men. The kidney function was positively correlated with ALT serum concentrations.

Cystatin C measurement leads to lower metformin dosage in elderly type 2 diabetic patients.

The aim of this study was to provide evidence for the hypothesis that estimated glomerular filtration rate from serum Cystatin C (eGFRcys) is better to be determined for all elderly type 2 diabetes mellitus (T2DM) patients based on eGFRcys upward and downward reclassification rate for hypothetical metformin dose reduction by eGFRcys at the GFR decision point of 45 mL/min/1.73 m2 . A total of 265 consecutive T2DM elderly patients (age range 65-91 years) from outpatient diabetic clinic were included in the study. The Kidney Disease Improving Global Outcomes (KDIGO) guidelines for metformin dosing were strictly followed. Estimated glomerular filtration rate from serum creatinine (eGFRcrea) led to results of metformin eligibility. Each of the results of eGFRcrea-based eligibility was further compared to eGFRcys-based eligibility. Creatinine was measured by enzymatic method standardized against international reference material SRM 967. Cystatin C was determined by method traceable to DA ERM 471 international standard. eGFRcrea and eGFRcys were calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations. A downward reclassification rate was higher than upward reclassification rate (31 vs 3, respectively; P < 0.0001). The median (IQR) eGFRcrea was higher than eGFRcys (73 (58-85) vs 63 (50-75) mL/min/1.73 m2 , respectively; P < 0.0001). eGFRcys reclassified significant proportion of patients with T2DM from metformin eligible CKD stages to less or non-eligible stages. The downward reclassification was more frequent in patients older than 80 years (P < 0.01). Cystatin C-based eGFR selects more complicated patients, where lower doses of metformin are possibly advisable. We recommend calculating both eGFRcrea and eGFRcys for metformin dosing in elderly patients with T2DM.

Effectiveness and safety of lixisenatide for treatment of diabetes in the real world: data from the Monitoring Registry in a Real-Life Cohort in the Czech and Slovak Republic.

INTRODUCTION: GLP1 receptor agonist lixisenatide has demonstrated its efficacy in numerous clinical trials, nevertheless its real-life effectiveness data is limited. AIM: To describe effectiveness and safety of lixisenatide in routine clinical practice in the Czech Republic and the Slovak Republic, as recorded by the Registry-Based Observational Study. METHODS: Multinational, multicenter, observational, non-interventional, 6-month prospective product registry of patients with type 2 diabetes mellitus aged > 18 years who were initiating therapy with lixisenatide. Patients were enrolled into this registry, provided written informed consent, between 1 May 2013 and 31 December 2015. Evaluations were performed at baseline and after 3 and 6 months of lixisenatide treatment. The primary objective of the study was the absolute change in glycated hemoglobin (HbA1c) from baseline to month 6 after lixisenatide initiation. The study was approved by responsible ethics committees and performed in accordance with the Helsinki Declaration. Informed consent was obtained from all patients before enrolment in the study. RESULTS: Overall 772 eligible patients (51.4 % males), mean age 56.7 (± 9.3) years, with mean diabetes duration 7.7 (± 5.5) years, mean duration of treatment with oral antidiabetic drugs 6.8 (± 4.9) years, and body mass index 37.6 (± 5.9) kg/m2 were enrolled in the study. Overall, 93.6 % were obese, 86.3 % subject were treated for hypertension, and 76.0 % for dyslipidemia. In total 96.1 % of patients completed the 6 months therapy. Lixisenatide significantly reduced HbA1c (decrease by 9.7 ± 14.4 mmol/mol [3.1 ± 0.2 % DCCT] after 6 months in per protocol population), and body weight (decrease by 3.5 ± 5.4 kg). The best responders to the treatment were younger patients with higher BMI, who had a shorter duration of diabetes. Overall safety profile of lixisenatide was satisfactory in the study. The most frequent adverse events were functional disorders affecting the gastrointestinal system. There was no episode of severe hypoglycemia reported throughout the study. CONCLUSION: In a real-life practice cohort of patients with type 2 diabetes mellitus 6 months treatment with once-daily GLP1 receptor agonist lixisenatide significantly improved glucose control and decreased body weight without increasing the risk of symptomatic and/or severe hypoglycemia risk. FUNDING: Sanofi Czech Republic.Key words: GLP1 receptor agonist - glycated hemoglobin - HbA1c - lixisenatide - oral antidiabetic drugs (OAD) - observational study - hypoglycemia - type 2 diabetes mellitus.